Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Melatonin
Drug ID BADD_D01373
Description Melatonin is a biogenic amine that is found in animals, plants and microbes. Aaron B. Lerner of Yale University is credited for naming the hormone and for defining its chemical structure in 1958. In mammals, melatonin is produced by the pineal gland. The pineal gland is small endocrine gland, about the size of a rice grain and shaped like a pine cone (hence the name), that is located in the center of the brain (rostro-dorsal to the superior colliculus) but outside the blood-brain barrier. The secretion of melatonin increases in darkness and decreases during exposure to light, thereby regulating the circadian rhythms of several biological functions, including the sleep-wake cycle. In particular, melatonin regulates the sleep-wake cycle by chemically causing drowsiness and lowering the body temperature. Melatonin is also implicated in the regulation of mood, learning and memory, immune activity, dreaming, fertility and reproduction. Melatonin is also an effective antioxidant. Most of the actions of melatonin are mediated through the binding and activation of melatonin receptors. Individuals with autism spectrum disorders (ASD) may have lower than normal levels of melatonin. A 2008 study found that unaffected parents of individuals with ASD also have lower melatonin levels, and that the deficits were associated with low activity of the ASMT gene, which encodes the last enzyme of melatonin synthesis. Reduced melatonin production has also been proposed as a likely factor in the significantly higher cancer rates in night workers.
Indications and Usage Used orally for jet lag, insomnia, shift-work disorder, circadian rhythm disorders in the blind (evidence for efficacy), and benzodiazepine and nicotine withdrawal. Evidence indicates that melatonin is likely effective for treating circadian rhythm sleep disorders in blind children and adults. It has received FDA orphan drug status as an oral medication for this use. A number of studies have shown that melatonin may be effective for treating sleep-wake cycle disturbances in children and adolescents with mental retardation, autism, and other central nervous system disorders. It appears to decrease the time to fall asleep in children with developmental disabilities, such as cerebral palsy, autism, and mental retardation. It may also improve secondary insomnia associated with various sleep-wake cycle disturbances. Other possible uses for which there is some evidence for include: benzodiazepine withdrawal, cluster headache, delayed sleep phase syndrome (DSPS), primary insomnia, jet lag, nicotine withdrawal, preoperative anxiety and sedation, prostate cancer, solid tumors (when combined with IL-2 therapy in certain cancers), sunburn prevention (topical use), tardive dyskinesia, thrombocytopenia associated with cancer, chemotherapy and other disorders.
Marketing Status approved; nutraceutical; vet_approved
ATC Code N05CH01
DrugBank ID DB01065
KEGG ID D08170
MeSH ID D008550
PubChem ID 896
TTD Drug ID D0AN7B
NDC Product Code 52119-021; 51552-0844; 51927-5114; 63083-1527; 54236-040; 44911-0194; 52119-018; 52119-017; 43857-0086; 68210-0204; 43742-0771
UNII JL5DK93RCL
Synonyms Melatonin
Chemical Information
Molecular Formula C13H16N2O2
CAS Registry Number 73-31-4
SMILES CC(=O)NCCC1=CNC2=C1C=C(C=C2)OC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Tension19.06.02.005--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus04.04.01.002; 17.04.07.0040.000790%
Tongue disorder07.14.01.002--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tongue ulceration07.14.01.0030.000232%Not Available
Tremor17.01.06.002--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence17.05.01.008; 20.02.02.0100.000232%
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.0010.000790%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000628%
Vertigo04.04.01.003; 17.02.12.002--
Vertigo positional04.04.01.005; 17.02.12.004--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Lymphatic disorder01.09.01.003--Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Infusion site swelling12.07.05.003; 08.02.05.0020.000232%Not Available
Infusion site pruritus23.03.12.006; 12.07.05.005; 08.02.05.0040.000232%Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.0020.000232%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000232%
Hand dermatitis23.03.04.032--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
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